Hybrid Validation Analyst - Life Sciences QA & Compliance

Regulatory Jobs; Town of Middleton (WI); Hybrid; USD 65,000 - 95,000; Full time

Job summary

Thermo Fisher Scientific's PPD Laboratory Services is seeking a QA/Validation Specialist to provide basic business/system support of software systems and laboratory instrumentation, participate in PQ validation, and facilitate system upgrades.

You will prepare validation plans, test cases, execute tests, review change controls, and ensure PV meets business needs while complying with SOPs and regulatory requirements. Hybrid role based in Middleton, WI with onsite onboarding.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 2+ years of experience in a related role or equivalent
• Equivalency may be considered with relevant education, training or experience

Responsibilities

• Participates as a validation representative at project team meetings and completes assigned action items; provides direction for future releases to software systems; reviews and approves/rejects change requests; communicates with project team members and management.
• Provides validation support for new releases and modifications to applications throughout the SDLC; prepares validation plans, test cases and validation summary reports; executes test cases.
• Reviews and approves all change controls for validated systems per SOP; reviews PQ and change control documentation with leadership per SOP.
• Ensures test scripts cover functional requirements and demonstrate that the application meets business expectations.
• Executes test scripts to provide evidence that systems perform correctly; creates/updates data in testing environments; works with leadership to address PQ issues from audits.
• Manages assignments to meet deadlines and deliver high-quality work; adheres to contractual obligations and SOPs.
• Participates in identifying user requirements and system design; assists in preparing and reviewing system documents such as requirements and design specs.

Skills

Client-focused

Interpersonal skills

Communication skills

Attention to detail

Problem solving

Time management

SDLC knowledge

GCPs knowledge

Teach others

Team collaboration

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Microsoft Project

Job description

Thermo Fisher Scientific's PPD Laboratory Services is seeking a QA/Validation Specialist to provide basic business/system support of software systems and laboratory instrumentation, participate in PQ validation, and facilitate system upgrades.

You will prepare validation plans, test cases, execute tests, review change controls, and ensure PV meets business needs while complying with SOPs and regulatory requirements. Hybrid role based in Middleton, WI with onsite onboarding.